Registration Dossier
Registration Dossier
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EC number: 806-919-0 | CAS number: 1356964-77-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according OECD guideline, GLP, well documented. Reliability reduced for read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-dimethyldecan-1-amide
- EC Number:
- 238-405-1
- EC Name:
- N,N-dimethyldecan-1-amide
- Cas Number:
- 14433-76-2
- IUPAC Name:
- N,N-dimethyldecanamide
- Details on test material:
- - Name of test material (as cited in study report): SAT 970 419, Decansäuredimethylamid
- Chemical name: N,N-Dimethyldecan-1-amide
- Physical state: liquid
- Lot/batch No.: Ch. 1/96
- Expiration date of the lot/batch: June 1998
- Storage condition of test material: room temperature, darkness
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623
- Weight: 2.3-2.5 kg
- Housing: animal room 2, filtered Air, ppo cages
- Diet (e.g. ad libitum): ad libitum / Altromin 2123 , Altromin , Lage , Germany
- Water (e.g. ad libitum): ad libitum (acified, HCl)
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10times/h
- Photoperiod (hrs dark / hrs light):12h each
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4h
- Observation period:
- 1h, 24h, 48h, 72h, 7d, 14d, 21d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Clipped area: 10*10cm
- Area of exposure: 2.5cm*2.5cm
- % coverage: 100
- Type of wrap if used: 16-layer gaze fixed with 2.5cm adhesive Gothaplast tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin was cleaned with mild soap and lukewarm water
- Time after start of exposure: 4h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Erythema and Eschar Formation
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- other: mean of 24h, 48h and 72h reading
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: after 21 days rests of scales were observed in all animals
- Irritation parameter:
- edema score
- Remarks:
- Oedema Foramtion
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- other: mean of 24h, 48h and 72h reading
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: after 21 days rests of scales were observed in all animals
- Irritant / corrosive response data:
- no evidence for corrosion reported
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- irritating to skin
- Executive summary:
The acute skin irritant effect of SAT 970 419 was investigated according to the method
recommended in the OECD Guideline No. 404, "Acute Dermal Irritation/Corrosion", 1992, and
EEC Guideline B.4 "Acute Toxicity (Skin Irritation)", 29.12.1992.
Three female albino rabbits were exposed to the test article at two skin sites on the back. After 4
hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours
as well as 7, 14 and 21 days after termination of exposure.
Moderate to severe skin reactions were observed.
Under the experimental conditions described in this report, the mean score for erythema was 2.7 (2.00, 3.00, 3.00)
and for oedema 2.8 (2.00, 3.33, 3.00). After 21 days rests of scales on both sides were observed in all animals.
Based on this result the substance has to be labeled as irritating to skin according to EU GHS EC 1272/2008.
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